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Posts by category
- Category: Guidelines
- Site Master File – EU GMP
- 21 CFR Part 211-cGMP
- Containers-Glass
- Self Inspection – EU GMP
- Complaints and Product Recalls – EU GMP
- Outsourced Activities – EU GMP
- Production – EU GMP
- Documentation – EU GMP
- Premises and Equipment – EU GMP
- Personnel – EU GMP
- Pharmaceutical Quality System – EU GMP
- SCHEDULE M-II
- SCHEDUE M-I
- SCHEDULE M – GMP – PART 7 (API-BULK DRUGS)
- SCHEDULE M – GMP – PART 6 (METERED-DOSE-INHALERS)
- SCHEDULE M – GMP – PART 5 (TOPICAL PRODUCTS)
- SCHEDULE M – GMP – PART 4 (ORAL LIQUIDS)
- SCHEDULE M – GMP – PART 3 (PARENTERAL PREPARATIONS)
- SCHEDULE M – GMP – PART 2 (OSD)
- Data Integrity – ALCOA+
- What is CAPA – Corrective and preventative action
- ICH Guidelines
- Category: Method of Analysis
- Category: Microbiology
- Microbiological Control Tests
- Aseptic Processing – Sterile Pharmaceutical
- SOP for Entry and Exit Procedure in Microbiology Lab
- Preparation and Destruction of Media for Microbiological Analysis – SOP
- Subculturing of Master and Maintenance of Microbiological Cultures – SOP
- Receiving and Maintaining the Stock of Media – SOP
- Qualification of Autoclave – SOP
- Microbiological Qualification of Area – SOP
- Microbial Limit Test for Raw Materials – SOP
- Category: Packaging Material
- Bursting Strength Tester
- SOP for Bursting Strength Tester
- Packaging Material Vendor Audit Checklist
- Poly laminated aluminium tagger – Packaging material standard test procedure
- HDPE Jar – Packaging material standard test procedure
- Cap for HDPE Jar – Packaging material standard test procedure
- Poly bag – Packaging material standard test procedure
- Silica gel bag – Packaging material standard test procedure
- Poly laminated foil (printed) – Packaging material standard test procedure
- Cold forming aluminium foil – Packaging material standard test procedure
- Cold forming aluminium foil – Packaging material standard test procedure
- Cap for glass bottle – Packaging material standard test procedure
- Glass Bottle – Packaging material standard test procedure
- Sticker label – Packaging material standard test procedure
- Leaflet – Packaging material standard test procedure
- LDPE BAGS – Packaging material standard test procedure
- BOPP TAPE– Packaging material standard test procedure
- Strapping Roll – Packaging material standard test procedure
- Shrink– Packaging material standard test procedure
- PVC Film – Packaging material standard test procedure
- Aluminium Foil (Printed) – Packaging material standard test procedure
- Corrugated Box– Packaging material standard test procedure
- Catch Cover– Packaging material standard test procedure
- Cartons – Packaging material standard test procedure
- Category: Quality Assurance
- SCHEDULE M – GMP – PART 1
- Self Inspection Checklist
- Rinse and Swab Sampling From Equipment’s Product Contact Surface SOP
- Usage Entry on Log Books SOP
- Handling of Hazardous Chemicals SOP
- Allocating identification number to instrument / equipment / utility
- Specimen Signature SOP
- Preparation of User Requirement Specification (URS) SOP
- Handling of Out Of Trend (OOT) SOP
- Out of Specification Flow Chart of Investigation for different Phases
- Flowchart for Quality Risk Management and Quality Risk Management Process
- Quality Risk Management SOP
- Reconciliation During Batch Manufacturing and Batch Packing SOP
- Temperature Mapping SOP
- Management of Batch Manufacturing Record and Batch Packing Record SOP
- Calibration By External Agency SOP
- Sampling of Intermediate and Finished Product SOP
- Stability Studies SOP
- Handling of Online Rejection SOP
- Corrective Action and Preventive Action (CAPA) SOP
- Failure Investigation SOP
- Incident Management SOP
- In Process Quality Assurance (IPQA) SOP
- Annual Product Quality Review (APQR) SOP
- Line Clearance SOP
- Cleaning Validation SOP
- Approval of Finished Goods SOP
- Qualification of Equipment / Instrument / Utilities SOP
- Out of Specification SOP
- Handling of Returned Goods SOP
- Assigning Manufacturing and Expiry Date SOP
- Allocation of Product Batch Number SOP
- Change Control Flow Chart
- Handling of Market Complaints SOP
- Product Recall Flow Chart
- Product Recall SOP
- Self Inspection SOP
- Vendor Qualification SOP
- Change Control SOP
- Training SOP
- Handling of Deviation – SOP
- Documentation – SOP
- Preparation of Site Master File – SOP
- Preparation, review, approval, distribution control, revision, retrieval and destruction of standard operating procedure – SOP (SOP for SOP)
- Category: Quality control
- Glass Grains Test – USP
- STANDARD SOLUTIONS FOR LIMIT TESTS
- SCHEDULE L-1 (GLP)
- Calibration of Gas Chromatography SOP
- Analyst Qualification Criteria
- Disintegration Test
- Karl Fischer Titration
- Residue on ignition / Sulfated ash
- Loss on drying
- Dissolution Test
- SOP for Hardness Tester
- Out of Specification (OOS)
- Daily Maintenance and Common problems in HPLC
- INFRARED ABSORPTION SPECTROSCOPY
- Tap Density Tester SOP
- Quality Control – Principle, General information
- HPLC Basics- Principle and Scope
- Good Laboratory Practice – GLP
- SOP for Operation and Calibration of Total Organic Carbon analyzer. (TOC)
- Rounding off Analytical Results SOP
- Analytical Method Transfer SOP (AMT)
- Electrolab Friability Test Apparatus SOP
- Electrolab Disintegration Test Apparatus SOP
- SOP of Desiccator
- Operation of Viscometer SOP
- Operation of High Performance Liquid Chromatography (HPLC) SOP
- Operation of Dissolution Test Apparatus SOP
- Testing and Release of In process samples, Semi Finished Products and Finished Product
- Sampling, Testing and Release of Water and Pure Steam
- Operation and Calibration of Disintegration Test Apparatus SOP
- Good Laboratory Practice SOP
- Operation of Micrometer Screw Gauge SOP
- Operation of Reverse Laminar Air Flow Unit SOP
- Operation and Calibration of Hot Air Oven SOP
- Operation and Calibration Of UV Cabinet SOP
- Operation and Calibration of Polarimeter SOP
- Operation and Calibration of Refractometer SOP (Make-Rajdhani)
- Operation and Calibration of Friability Test Apparatus SOP
- Analyst Qualification SOP
- Adjustment of Chromatographic Conditions as per BP / USP (for HPLC)
- Good Chromatographic Practices SOP
- Audit Trail SOP
- Investigating and Handling of Out Of Trend (OOT) Test Results SOP
- Investigating and Handling Of Out Of Specification (OOS) Test Results SOP
- Handling of Out Of Calibration (OOC) SOP
- Handling of The Spillage SOP
- Cleaning of Glassware in Laboratory SOP
- Calibration of Dissolution Test Apparatus SOP
- Operation and Calibration of pH Meter/ Conductivity Meter
- Operation of Ultrasonic Cleaner SOP
- Cleaning and Operation of COD Digester SOP
- Operation of Digital Micrometer SOP
- Operation and Calibration of Karl Fischer Titrator SOP
- Calibration of Fourier Transform Infra-red Spectrophotometer (FTIR) SOP
- Calibration of High Performance Liquid Chromatography (HPLC) SOP
- Calibration of Ultraviolet Visible Spectrophotometer SOP
- Calibration of Analytical Balance SOP
- User Requirement Specification Example – InstrumentÂ
- Abbreviations SOP
- Inventory of Reagents/Indicators and Other Items SOP
- Calibration of Glass Apparatus SOP
- Analytical Method Validation SOP
- Shelf life of Volumetric Solutions – SOP
- Preparation, Standardisation and Storage of Laboratory Solutions – SOP
- Contract Laboratory Approval and Contract Analysis – SOP
- HPLC Column Management – SOP
- Preparation and Handling of Working Standards – SOP
- Procurement and Handling of Reference Standards – SOP
- Disposal of Laboratory Waste – SOP
- Handling of Raw Material Under Retest Due – SOP
- Analysis of Raw Materials – SOP
- Analytical Specifications, Standard Test Procedures and Worksheets – SOP Â
- Control Sample Management-SOP
- Entry And Exit from Quality Control Department-SOP
- Sampling of Raw material and cleaning of sampling aids-SOP
- Opening and Closing of the Quality Control Department – SOP
- Category: SOP
- Water Sampling Procedure for Microbiological analysis
- Purity Testing of Microbiological Cultures – SOP
- Microbial Limit Test for Finished Products – SOP
- Microbial Limit Test For Primary Packaging Materials – SOP
- Microbial Evaluation By Swab Method – SOP
- Cleaning and operation of Laminar Air Flow (LAF)-SOP
- Cleaning and operation of colony counter-SOP
- Cleaning and operation of light microscope-SOP
- Cleaning and operation of zone reader-SOP
- Growth Promotion Test-SOP
- Cleaning and Operation of Refrigerators-SOP
- Cleaning and Operation of Incubators-SOP
- Receiving, Issuance and Verification of Biological Indicators-SOP
- Destruction of Microbial Waste-SOP
- Destruction and Disposal of Expired Media-SOP
- Cleaning In Microbiology Section-SOP
- Sampling, Testing and Approval/Rejection of Packaging Material – SOP
- Validation Master Plan – SOP
- Checking personnel hygiene by dab test method-SOP
- Category: Validation